MedPath

Management of Uterine Leiomyomata and Adenomyosis

Conditions
Abnormal Uterine Bleeding
Interventions
Registration Number
NCT05153928
Lead Sponsor
Ahmed Ali Mahmoud
Brief Summary

1. to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination

2. to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma

Detailed Description

The aim of the present study is:

1. to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination

2. to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
100
Inclusion Criteria
  • (1) age≥30 years; (4) dysmenorrhea, adenomyosis-associated chronic pain, and/or menorrhagia.

(3) regular menstrual cycles before administration of norethisterone; (4) no other treatment for adenomyosis/leiomyomatosis at least for 3 months biopsies and histopathology for operated patients;

Exclusion Criteria
  • (1) pregnant and/or breast-feeding women (2) patients with a ovarian neoplasm, benign ovarian cyst including endometrioma, pelvic inflammatory disease or other endocrine diseases.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
fibroid casesNorethisterone acetateNorethisterone acetate for 5 months
adenomyosisNorethisterone acetateNorethisterone acetate for 5 months
Primary Outcome Measures
NameTimeMethod
is to evaluate sensitivity and specificity of hysteroscopy in differentiating between uterine adenomyosis and leiomyomatosis6 months

Symptomatic improvement

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Ahmed Ali

🇪🇬

Assiut, Egypt

Maternaty hospital in assiut

🇪🇬

Assiut, Egypt

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